Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Scientist working in laboratory-GettyImages-2215842283

Ask The Pros — The Latest In Downstream HCP Mitigation

Two downstream biologics processing experts address some of the field's complex, nagging questions about mitigating host cell proteins.

GUEST COLUMNISTS

EMA Guideline On Clinical-Stage ATMPs Comes Into Effect: On The Verge Of Convergence?
On July 1, 2025, the EMA’s Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials is slated to come into effect.
Formulation Development Of A JAK1 Inhibitor Extended-Release Tablet
This scientific article presents a summary of the formulation development strategy of a JAK1 inhibitor extended-release tablet, with a focus on experimental design, data interpretation, and formulation decision-making.
Exploring The Market For Closed-Loop Cell Therapy Production
The second part of a discussion on closed-loop systems explores the CDMO and equipment landscape for scaling automated closed loop cell therapy manufacturing systems.
Closed-Loop Manufacturing Is The Cell Therapy Revolution We Need
In cell therapy manufacturing, automated closed systems with integrated software controls offer numerous benefits over traditional open systems.
What Global Survey Says About Scant Patient Access To CAR-T Therapy
The Worldwide Network for Blood and Marrow Transplantation initiated a survey to understand cost, infrastructure, and regulatory differences affecting access.
Scaling Up Manufacturing? Here's Why You Need A CMC Specialist
CMC experts (whether in-house or outsourced) fill a vital role during the transition from small-scale production to larger operations for maintaining quality, consistency, and compliance.
Amgen Bets On Agility In The Age Of AI
The company is speeding up process optimization with tools like predictive analytics, digital twins, and generative AI copilots.
Peeling Back The Layers Of Radiolabeled Peptide Production
From the moment radiolabeled drugs are made, it’s a race to get them to patients. Radioactive decay is just one of many complications. Here’s one company’s approach.

PHARMA OUTSOURCING WHITE PAPERS

Overcoming Challenges To High-Concentration Formulation Development
Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.

Outsourcing Stability Storage: A Cost-Effective And Quality-Driven Approach
Partnering with a leader in outsourced stability storage is revolutionizing the pharmaceutical and medical device industry by saving costs and resources, and ensuring product quality and compliance.
A New Framework For Identifying Nitrosamine Risks And Derisking Products
Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.
Vial Fogging: Practical Considerations For Vial Selection
Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.
Mitigating Nitrosamine Risks In Pharmaceuticals
Nitrosamines can come from a range of sources, including raw materials, manufacturing processes, and even water sources. Detecting them requires sensitive analytical methods.
The Relevance Of Polymorph Screening In The Pharmaceutical Industry
Polymorph screening identifies different solid forms of active pharmaceutical ingredients, optimizing drug stability, solubility, and manufacturability. This process ensures quality, regulatory compliance, and intellectual property protection in pharmaceutical development.